Antivirals & Antitoxins Program David Boucher, PhD Project Officer, CBRN Antivirals and Antitoxins October 29, 2018 October 29-30, 2018 | Grand Hyatt • Washington, D.C. BARDA Chemical Biological Radiological & Nuclear Portfolio at a Glance: Antivirals & Antitoxins Branch IND NDA/BLA Preclinical Production Discovery Phase I Phase II Phase III Licensure Development & Delivery Filovirus Antiviral Smallpox Antiviral Anthrax Antitoxin Filovirus Antiviral Botulism Antitoxin Smallpox Antiviral Saving Lives. Protecting Americans. 2 Anthrax Antitoxin Program OBJECTIVE Develop safe and effective anthrax antitoxins to treat inhalational anthrax Approved Products: All three products are in the Strategic National Stockpile and Raxibacumab NOV available for deployment 2012 (Emergent, formerly GSK & HGS) MAR AIG IV (Anthrasil) 2015 (Emergent, formerly Cangene) MAR Obiltoxaximab (Anthim®) 2016 (Elusys) Saving Lives. Protecting Americans. 3 Anthrax Antitoxins: Program Strategy and Opportunities Continuing Program Opportunities Efforts Objectives • Coordinate with industry • Further diversify the • BARDA BAA, AOI #2.1, solicits and ASPR/SNS to ensure portfolio and, in turn, TRL-6 or greater candidates that medical countermeasure our response meet one or more of the following preparedness capabilities requirements: • Extend shelf-life and • Are peptides, small molecules or improve concept of novel compounds; operations of existing • Have a unique mechanism of action; products • Provide a transformational change in • Support completion of operational use; post-marketing • Provide a transformational change in commitments Total Life Cycle Costs Saving Lives. Protecting Americans. 4 Botulinum Antitoxin Program OBJECTIVE Develop safe and effective botulism antitoxins to treat botulism intoxication caused by serotypes A-G Approved Products: MAR hBAT Emergent, formerly Cangene) 2013 hBAT is in the Strategic National Stockpile and available for deployment Saving Lives. Protecting Americans. 5 Botulinum Antitoxins: Program Strategy and Opportunities Continuing Program Opportunities Efforts Objectives • Coordinate with industry • Further diversify the • BARDA BAA, AOI #2.2, solicits and ASPR/SNS to ensure portfolio and, in turn, candidates that meet one or more of the medical countermeasure our response following requirements: preparedness capabilities • Are mAbs, peptides, small molecules or novel • Support post-marketing compounds; commitments • Have a unique mechanism of action; • Provide a transformational change in operational use; • Provide a transformational change in Total Life Cycle Costs • Candidates at TRL-5 are preferred; however, earlier candidates can be considered based on program impact Saving Lives. Protecting Americans. 6 Smallpox Antiviral Program OBJECTIVE Develop safe and effective treatment options (multiple antiviral drugs with different mechanisms of action) for individuals with smallpox disease Approved Products: JUL ST-246/TPOXX ST-246/TPOXX is in the 2018 (SIGA) Strategic National Stockpile and available for deployment Ongoing Program: CMX-001/Brincidofovir (Chimerix) Saving Lives. Protecting Americans. 7 Smallpox Antivirals: Program Strategy and Opportunities Continuing Program Opportunities Efforts Objectives • Coordinate with industry • Further diversify the • BARDA BAA, AOI #2.3, solicits and ASPR/SNS to ensure portfolio and, in turn, candidates with evidence of antiviral medical countermeasure our response activity against orthopoxviruses. preparedness capabilities • Candidates at TRL-5 are • Extend shelf-life and preferred; however, earlier improve concept of candidates can be considered operations of existing based on program impact products • Support completion of post-marketing commitments Saving Lives. Protecting Americans. 8 Filovirus Antiviral Program (Ebola Zaire) OBJECTIVE Develop safe and effective treatment options for individuals with viral hemorrhagic fever caused by filovirus infection ARD Program PBS Program PBS Program Galidesivir/BCX4430 (BioCryst) ZMapp (Mapp Biopharmaceutical) REGN-EB3 (Regeneron) Both ZMapp and REGN-EB3 are being made available under EAP/MEURI Saving Lives. Protecting Americans. 9 Filovirus Antiviral Program (Sudan and Marburg) OBJECTIVE Develop safe and effective treatment options for individuals with viral hemorrhagic fever caused by filovirus infection Manufacturing material that “Innovation” ARD Program could be used as part of a MBP091 (Mapp Biopharmaceutical) response to • Targets the Marburg virus MBP134 (Mapp Biopharmaceutical) outbreaks/high-risk • Targets the Sudan virus exposures for which there are no available MCMs is a ARD Program priority MBP134 (Mapp Biopharmaceutical) Saving Lives. Protecting Americans. 10 Filovirus Antiviral Program Strategy & Opportunities Continuing Program Opportunities Efforts Objectives • Advance PBS Programs to • Further diversify the • BARDA BAA, AOI #2.2, solicits licensure and continue to Zaire portfolio candidates at TRL-5 or higher and, make those products for Ebola Zaire, meet one or more of available when needed • Build the Sudan and Marburg portfolios the following requirements: • Continue to support field • Are single mAbs, peptides, small use of filovirus molecules or novel compounds; therapeutics through EAP, RCT & MEURI • Have a unique mechanism of action; • Provide a transformational change in operational use; • Provide a transformational change in Total Life Cycle Costs Saving Lives. Protecting Americans. 11 BARDA’s Antivirals & Antitoxins Team Medical Countermeasures Contracts Management & Subject Matter Experts Program Acquisitions • Chia-Wei Tsai, Branch Chief • Clinical Development • Jason Bell • David Boucher • Pharmaceutical • Brooke Bernold • Clay Hughes Countermeasure • Wendell Conyers • Malen Link Infrastructure • Erin Greninger • Michael Merchlinsky • Non-clinical • Phil Hastings Development • Kimberly Sciarretta • Francine Hemphill • Regulatory & Quality • David Simon Assurance • Ethan Muller • Danielle Turley • Oke Obi • Carol Diaz-Diaz, ORISE Fellow • Matthew Rose Saving Lives. Protecting Americans. 12 How to contact BARDA medicalcountermeasures. www.fbo.gov/ https://www.phe.gov/about/ www.drive.hhs.gov gov/home.aspx (“FedBizOpps”) BARDA/Pages/default.aspx DRIVe questions Portal to BARDA: Register to Official announcements and Program description, information, request a TechWatch meeting! info for all government news, announcements contract solicitations https://www.usajobs.gov/ Join the team! Saving Lives. Protecting Americans. 13.